1. Field of the Invention
The present invention relates generally to drug packaging. Particularly, the present invention relates to drug packaging systems and methods to reduce adverse drug events.
2. Description of the Prior Art
The manufacture and distribution of human drugs in the United States is regulated by the Food and Drug Administration (FDA). The FDA is charged with assessing all drugs for safety and efficacy and is also responsible for determining whether individual drugs are best distributed by prescription or over-the-counter. Prescription drugs, because of toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, are considered by the FDA as being not safe for use except under the supervision of a practitioner licensed by law to administer such drug. Over-the-counter drugs are drugs that the FDA has considered to have a limited potential for harmful effect sufficient to allow dispensing directly to lay users without the requirement of licensed practitioner supervision.
The FDA prohibits the sale or representation of a prescription drug other than by prescription, and the sale or representation of an over-the-counter drug other than by over-the-counter. A prescription drug is required, at minimum, to bear the symbol “RX only”, and is considered misbranded if at any time prior to dispensing its label fails to bear this. An over-the-counter drug is deemed misbranded if at any time prior to dispensing its label bears a prescription symbol. (The statutory authority for the FDA comes from the Federal Food, Drug and Cosmetic Act (the FDCA, 21 U.S.C. 301 et seq.) and this ruling is found in SEC. 503 (b)(4)).
Although administration under the supervision of a licensed practitioner is not required for over-the-counter drugs, FDA regulations do not prohibit practitioners from “prescribing” or recommending over-the-counter drugs to their patients. The terms “prescribe” and “recommend” in reference to over-the-counter drugs, are herein used synonymously. The recommending of over-the-counter drugs by a caregiver may be accomplished verbally or in writing, including writing on an ordinary prescription blank although not filled by the pharmacist in the manner of a prescription drug.
Despite the FDA efforts to regulate the dispensing of drugs, errors in the dispensing of drugs and consequent adverse effects are known to occur even in the most carefully supervised medical environments. For example, in a front page article entitled “Controls were urged before '95 overdose” on Jul. 12, 1996, the Boston Globe reported “a number of adverse events” including the death of a 67 year old patient due to potassium chloride overdose at Boston's Brigham and Woman's Hospital. It was noted that in the previous year Dr. David Bates published a research paper documenting how medications caused injuries to one of every 15 patients admitted to Brigham and Woman's, and Massachusetts General Hospitals over a six-month period. A Brigham and Woman's hospital committee came to recognize that if the hospital pharmacy were to only stock packaged, premixed solutions of potassium chloride, and not stock the current vials of concentrated potassium chloride, this would markedly reduce the chance of a future occurrence. Such a measure to prevent adverse effects can be referred to as a “system change” in the dispensing of the drug.
The extent of such problems is not limited. Three years later, on Nov. 30, 1999 both the Wall Street Journal and USA Today reported study findings of the Institute of Medicine, a private organization established by Congress to provide advice on medical issues. The study found that between 44,000 and 98,000 Americans die each year as a result of medical mistakes made while they are in the hospital, killing more Americans than traffic accidents, breast cancer or AIDS. Deaths were again noted to result from the stocking of drugs that should not be administered to patients unless they are diluted. The report took notice of “systemic flaws that . . . build the opportunity for error into medical practice.” A member of the Institute of Medicine committee, Dr. Lucien Leape of the Harvard School of Public Health, called for the nation's health care system to focus upon its systems rather than mistakes of individual caregivers.
In the article “Systems analysis of adverse drug events,” (JAMA 1995; 274: 35–43), Dr Leape, et al. reports that “errors in drug use are common, costly and often result in injury.” Further, that “. . . traditional efforts at error reduction have focused on individuals and episodes, using training, exhortation, rules and sanctions to improve performance. Human factors specialists and error experts reject this approach, noting that it is more effective to change the system as a whole to reduce the likelihood of accidents.” “Poor system design creates ‘accidents waiting to happen’.” To enhance safety by design, one would want to create a system “to make it difficulty for individuals to err.”
Over-the-counter drugs are generally considered as safe, but this may be misleading. Over-the-counter drugs are not risk-free. Unanticipated and serious adverse effects from unsupervised use of such common medications such as aspirin (peptic ulcer, intractable asthma) and first-generation antihistamines (industrial and motor vehicle injuries caused by impaired cognition) are well known. Some over-the-counter medications have proven to be clearly unsafe and have been removed because of their hazards. The taking of over-the-counter drugs together, or together with prescription drugs opens the door to unintended redundancy, overdose, and drug interactions.
When a caregiver prescribes a prescription drug to be filled by a pharmacy, the caregiver and patient can be reasonably certain that the patient will obtain the correct drug because of the continuous chain of supervision provided by the prescription-dispensing process. When a caregiver recommends an over-the-counter drug to a patient to be obtained at a pharmacy, the present system by which the FDA allows over-the-counter drugs only to be dispensed in that manner places the burden of correctly obtaining the recommended over-the-counter drug upon the patient. Lacking a continuous chain of professional supervision, there is considerably less certainty that the patient will obtain the correct drug.
For at least the following reasons, the procurement of over-the-counter drugs by lay persons can be considered a system that “creates accidents waiting to happen:”
1. The over-the-counter shelf is confusing. This is common knowledge, and can be validated by observing individuals attempting to select a cold remedy and having to differentiate between a myriad of products containing different ingredients in various proportions, each ingredient having its own therapeutic and side effects, and each formulation requiring different dosing timing. It is a certainty that individuals make inappropriate choices in selecting cold medications that, at least, result in unanticipated stimulation or unwanted sedation. Industrial accidents, motor vehicle accidents and aeronautical errors have been documented to be caused by these medications.
2. The ability to navigate the over-the-counter drug procurement process may be even more confusing for limited or impaired individuals.
3. The brand recommended by the physician may not be carried by the particular pharmacy used by the patient. If the patient does not find the particular over-the-counter recommended by the caregiver at his or her pharmacy, the patient may attempt to select a product that appears the same, or possibly forego treatment. Alternatively, the patient may seek the advice of a pharmacist. In the United States at present, the advisory services of pharmacists are not uniformly available to patients seeking help. It is often the case for pharmacists to be rushed and fully engaged in filling prescriptions. Even if assistance were fully available, however, the pharmacist would not have the caregiver's comprehensive knowledge of the patients' medical status and full understanding of the rationale for the caregiver's selection of medication.
4. A branded name may encompass many formulations. As with other retail commodities, over-the-counter drugs compete with each other at the retail shelf. Drug companies frequently develop multiple drug variations under the same brand name and can command increased shelf space in this manner. As an example, a patient suffering with acute sinusitis who is advised by his or her caregiver to procure “Afrin Nasal Spray®” might find one or more of: “Original”, “Extra Moisturizing”, “Severe Congestion”, “Allergy”, “Sinus”, or “Saline Mist” varieties upon reaching the pharmacy. If the “Afrin®” brand is not stocked, the patient might find another brand such as “Neo-Synepherin®”, but then have to deduce the utility of “Regular Strength”, “Extra Strength”, “Mild Formula”, and “Extra Moisturizing” preparations. Among these formulations are some with one decongestant, some with another decongestant, and some that have no decongestant at all.
5. The formulation of an over-the-counter product may change from time to time. It has been estimated that there are over 100,000 non-prescription over-the-counter products and changes can easily escape the caregiver's scrutiny and usually occur without notification to caregivers.
Therefore, what is needed is drug system and method that utilizes prescription and over-the-counter drugs in a coordinated system together to minimize error in patient procurement of over-the-counter medications. What is further needed is a drug system and method that provides greater control of the over-the-counter medications that the caregivers intend for their patients. What is also needed is a drug system and method that reduces the confusion and uncertainty created by the myriad of over-the-counter products from which a patient must differentiate.